The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial - Full Text View

Purpose

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

Condition	Intervention	Phase
Low Back Pain	Procedure: Active osteopathic manipulation and active ultrasound physical therapy Procedure: Sham osteopathic manipulation and active ultrasound physical therapy Procedure: Active osteopathic manipulation and sham ultrasound physical therapy Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:

Visual analogue scale score for pain [ Time Frame: 1, 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Roland Morris Disability Questionnaire [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study SF-36 Health Survey [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
Work disability [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
Satisfaction with back care [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	488
Study Start Date:	August 2006
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Active osteopathic manipulation and active ultrasound physical therapy	Procedure: Active osteopathic manipulation and active ultrasound physical therapy Active osteopathic manipulation and active ultrasound physical therapy
B Sham osteopathic manipulation and active ultrasound physical therapy	Procedure: Sham osteopathic manipulation and active ultrasound physical therapy Sham osteopathic manipulation and active ultrasound physical therapy
C Active osteopathic manipulation and sham ultrasound physical therapy	Procedure: Active osteopathic manipulation and sham ultrasound physical therapy Active osteopathic manipulation and sham ultrasound physical therapy
D Sham osteopathic manipulation and sham ultrasound physical therapy	Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy Sham osteopathic manipulation and sham ultrasound physical therapy

Detailed Description:

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

Eligibility

Ages Eligible for Study:	21 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
Must identify the low back as the primary site of pain
Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)

Exclusion Criteria:

History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
History of surgery involving the low back within the past year or planned low back surgery in the future
History of receiving Workers' Compensation benefits within the past three months
Involvement in current litigation relating to back problems
Current pregnancy or plan to become pregnant during the course of participation in the study
Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
Use of intravenous, intramuscular, or oral corticosteroids within the past month
History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315120

Locations

United States, Texas
The Osteopathic Research Center
Fort Worth, Texas, United States, 76107

Sponsors and Collaborators

University of North Texas Health Science Center

National Institutes of Health (NIH)

Osteopathic Heritage Foundations

Investigators

Principal Investigator:

John C. Licciardone, DO, MS, MBA

The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth

More Information

Publications:

Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. Review.

Licciardone JC, King HH, Hensel KL, Williams DG. OSTEOPAThic Health outcomes in chronic low back pain: The OSTEOPATHIC Trial. Osteopath Med Prim Care. 2008 Apr 25;2:5.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.

Responsible Party:	John C. Licciardone, D.O., M.S., M.B.A., The Osteopathic Research Center
ClinicalTrials.gov Identifier:	NCT00315120 History of Changes
Other Study ID Numbers:	06-02-20-1, NIH grant no.: K24 AT002422
Study First Received:	April 13, 2006
Last Updated:	May 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:

Randomized controlled trial
Low back pain
Spinal manipulative therapy
Spinal manipulation

Osteopathic manipulation
Osteopathic medicine
Physical therapy modalities

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013